MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE PKG, 32" 4K OLED SURGICAL DISPLAY; CAMERA, TELEVISION, SURGICAL, WITHOUT AUDIO

Catalog Number	0240031300
Medical Device Problem Codes	No Display/Image (1183); Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/07/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that there was loss of image.
Additional Manufacturer Narrative
Additional information will be provided once the investigation has been completed.The device manufacturer date is not known at this time.However, should it become available it will be provided in future reports.
Event or Problem Description
It was reported that there was loss of image.
Additional Manufacturer Narrative
This complaint investigation was closed based on the device not received, therefore the reported failure mode was not confirmed.In the event that the device is received, the complaint will be reopened and the investigation will be updated with new results.Alleged failure: intermittent live video output or partial image loss.Probable root cause: video cables are not sufficiently connected to ensure video.Intermittent failure of power supply.Intermittent failure of display voltage converter.User connects incompatible video source.Damaged pins of hdmi / dvi connector.Open / short circuit failure between video connectors, tconn board and main board failure / bug of scaler software.Incompatible cable used to connect video source to display.Scaler gain settings are not appropriate for the combination of source and cable being used.Emi / rf interference cybersecurity.Manufacture date is not known.

• Brand Name: PKG, 32" 4K OLED SURGICAL DISPLAY
• Common Device Name: CAMERA, TELEVISION, SURGICAL, WITHOUT AUDIO
• Manufacturer (Section D): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• Manufacturer (Section G): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• Manufacturer Contact: benjamin ly ; 5900 optical court; san jose, CA 95138 ; 4087542000
• MDR Report Key: 18387624
• Report Number: 0002936485-2023-01320
• Device Sequence Number: 19825229
• Product Code: FWB
• UDI-Device Identifier: 07613327592146
• UDI-Public: 07613327592146
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/10/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 0240031300
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/07/2023
• Supplement Date Received by Manufacturer: 12/07/2023
• Initial Report FDA Received Date: 12/22/2023
• Supplement Report FDA Received Date: 07/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown